FDA UDI In Commercial Distribution 🇺🇸 United States

SUCTION VALVE

DI: 04953170355912 · Model: MAJ-1443 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SUCTION VALVE
Primary DI
04953170355912
Version / Model
MAJ-1443
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
8
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
73685c83-3dd6-4768-bdcf-40ae5cd86c7d

Device Description

MAJ-1443 EUS suction valve, autoclave

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code Name
FDF Colonoscope and accessories, flexible/rigid
FDS Gastroscope and accessories, flexible/rigid
NWB Endoscope, accessories, narrow band spectrum

GMDN Terms

Code Name
61793 Endoscopic suction valve, reusable

Identifiers

Type ID
Primary 04953170355912

Customer Contacts